Promising data for Roche’s schizophrenia/NHL drugs

Good news from Roche came yesterday in the form encouraging data for two of its experimental drugs in mid-stage trials for the treatment of schizophrenia and non-Hodgkin’s lymphoma (NHL).

First up, eight-week results from a Phase II trial of the Swiss drugmaker’s first-in-class glycine reuptake inhibitor RG1678 showed that the drug was able to improve the negative symptoms of schizophrenia, as well induce beneficial changes in patients’ personal and social functioning.

Around 24 million people around the globe are affected by schizophrenia, but current treatments very much focus on addressing the positive symptoms of the disease, such as hallucinations and delusions. But this often leaves patients with uncontrolled negative symptoms, including loss of motivation and interest in social activities, Roche said, explaining RG1678’s place within the market.

“This new compound could be the first treatment to address the negative symptoms associated with schizophrenia, potentially enabling patients to carry out everyday tasks more effectively,” said Hal Barron, head of Global Development and chief medical officer at Roche, further explaining the drug’s potential.

Importantly, the multicentre, randomised, double-blind, parallel group, 323-patient study also showed that that RG1678 was generally well tolerated, adding further evidence in support of a favourable safety profile.

GA101 shines in NHL trial

Elsewhere, the drugmaker presented data at an American Society of Haematology meeting showing that GA101, a novel type II glyco-engineered monoclonal antibody targeting the CD20 protein found on cancerous B-cells, demonstrated “promising efficacy” in difficult-to-treat patients with the blood cancer NHL.

According to Roche, GA101 has been specifically designed to enhance the destruction of cancer cells by activating other immune cells to attack the cancer cells or by inducing direct cell death, and is the first of its kind to enter clinical trials in NHL and chronic lymphocytic leukaemia.

And thus far, results are encouraging, with two Phase II trials showing promising response rates in patients with either indolent or aggressive NHL who have failed to respond to multiple prior treatments, including Roche’s own Rituxan/MabThera (rituximab).

In the first Phase II study patients had received a median of three prior therapies and 63% had not responded to or had disease progression within six months of taking Rituxan/MabThera. Nearly a third of patients responded to treatment with GA101, and for those no longer responding to Rituxan/MabThera the response rate was 25% (in the 1600/800 mg group).

In the second trial in relapsed/refractory indolent NHL, patients had received a median of three prior treatments and 55% had not responded to/had disease progression within six months of Rituxan/MabThera. In the overall indolent NHL population, 55% of patients responded to GA101 with a promising median progression-free survival of 11.3 months (in the 1600/800mg group), and for those no longer responding to therapy the response rate was 50%.

“The performance of GA101 in this difficult-to-treat group of patients with NHL is encouraging, and we look forward to sharing more data from the extensive GA101 clinical development program in future,” Barron noted.